Guidance for Industry: Class II Special Controls Guidance Document: In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay; Availability, 44561-44562 [E7-15477]
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Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Notices
Industry: A Modified Lot-Release
Specification for Hepatitis B Surface
Antigen (HBsAg) Assays Used to Test
Blood, Blood Components, and Source
Plasma Donations’’ dated April 2002.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the FDA’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management written or electronic
comments (see ADDRESSES) regarding
the guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
HIV Drug Resistance Genotype Assay,’’
dated August 2007. The guidance
document provides a means by which in
vitro human immunodeficiency virus
(HIV) drug resistance genotype assays
may comply with special controls for
class II devices. Elsewhere in this issue
of the Federal Register, FDA is
publishing a final rule classifying the in
vitro HIV drug resistance genotype assay
into class II (special controls). The
guidance announced in this notice
finalizes the draft guidance entitled
‘‘Guidance for Industry: Premarket
Notifications [510(k)s] for In Vitro HIV
Drug Resistance Genotype Assays:
Special Controls’’ dated August 2001.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Food and Drug Administration
Submit written requests for
single copies of the guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Nathaniel L. Geary, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
[Docket No. 2001D–0286]
I. Background
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cber/guidelines.htm or
https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: August 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–15472 Filed 8–7–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Guidance for Industry: Class II Special
Controls Guidance Document: In Vitro
Human Immunodeficiency Virus Drug
Resistance Genotype Assay;
Availability
AGENCY:
Food and Drug Administration,
sroberts on PROD1PC70 with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Class II Special
Controls Guidance Document: In Vitro
SUMMARY:
VerDate Aug<31>2005
19:14 Aug 07, 2007
Jkt 211001
ADDRESSES:
FDA is announcing the availability of
a document entitled ‘‘Guidance for
Industry: Class II Special Controls
Guidance Document: In Vitro HIV Drug
Resistance Genotype Assay,’’ dated
August 2007. This guidance document
was developed as a special control to
support classification of the in vitro HIV
drug resistance genotype assay from
class III to class II (special controls).
Also, it is intended for use in detecting
HIV genomic mutations that confer
resistance to specific antiretroviral
drugs as an aid in monitoring and
treating HIV infection.
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
44561
In the Federal Register of August 29,
2001 (66 FR 45682), FDA announced the
availability of the draft guidance
entitled ‘‘Guidance for Industry:
Premarket Notifications [510(k)s] for In
Vitro HIV Drug Resistance Genotype
Assays: Special Controls’’ dated August
2001. FDA received several comments
on the draft guidance and those
comments were considered as the
guidance was finalized. The guidance
announced in this notice finalizes the
draft guidance entitled ‘‘Guidance for
Industry: Premarket Notifications
[510(k)s] for In Vitro HIV Drug
Resistance Genotype Assays: Special
Controls’’ dated August 2001.
II. Significance of the Guidance
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E (regulations
governing premarket notification
submissions) have been approved under
OMB control number 0910–0120.
IV. Comments
Interested persons may, at any time,
submit written or electronic comments
to the Division of Dockets Management
(see ADDRESSES) regarding this
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/cber/guidelines.htm or
https://www.fda.gov/ohrms/dockets/
default.htm.
E:\FR\FM\08AUN1.SGM
08AUN1
44562
Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Notices
Dated: August 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–15477 Filed 8–7–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice and request for
comments.
AGENCY:
SUMMARY: The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public and other
Federal agencies to take this
opportunity to comment on a proposed
revised information collection. In
accordance with the Paperwork
Reduction Act of 1995, this notice seeks
comments concerning the continued use
of FEMA Form 95–22, Application for
Admission, that is used to select
participants for the U.S. Fire
Administration (USFA) Executive Fire
Officer Program (EFOP).
SUPPLEMENTARY INFORMATION: Public
Law 93–498, the Fire Prevention and
Control Act of 1974, created the
National Fire Academy (NFA) which
provides for courses and programs to
train fire service personnel. Since 1985
USFA/NFA has sponsored and offered
the EFOP, a professional development
program for senior and executive level
fire officers. The standard application
form (FEMA Form 75–5, approved
under OMB No. 1660–0005), used for all
USFA/NFA courses, does not provide
the sufficient information to select the
most qualified applicants for the
program. FEMA Form 95–22 will
require a brief essay for questions
specific to EFOP functions.
Collection of Information
Title: National Fire Academy
Executive Fire Officer Program
Application Form.
Type of Information Collection:
Revision of a currently approved
collection.
OMB Number: 1660–0021.
Form Numbers: FEMA Form 95–22,
Application for Admission.
Abstract: The EFOP annually receives
more applications from qualified
applicants than there are program slots
available. Additional information is
required to objectively evaluate the
applicant’s writing capability,
professional accomplishments, and
analytical ability. This information
along with supporting documentation
are used to select the most qualified
participants for the EFOP.
Affected Public: Individuals and
households, and State, local or tribal
governments.
Estimated Total Annual Burden
Hours: 800 hours.
ANNUAL HOUR BURDEN
No. of
respondents
Frequency of
responses
Hour burden
per
response
Annual
responses
Total annual
burden hours
(A)
Data collection activity/instrument
(B)
(C)
(D) = (A×B)
(C×D)
400
1
1
400
400
400
1
1
400
400
Total ..............................................................................
sroberts on PROD1PC70 with NOTICES
FEMA Form 95–22 ..............................................................
Additional Documentation: Letter of Intent, Resume, Letter
of Recommendation, Diploma Photocopy, Organizational Chart .......................................................................
400
........................
........................
........................
800
Estimated Cost: Therefore; the
estimated cost to respondents using
wage rate categories is estimated to be
$55,616.00 and the cost for postage and
mailing to respondents is estimated to
be $1,960.00 annually. The annual cost
to respondents is estimated to total
$57,576.00. The annual cost to the
government for spending time reviewing
FEMA Form 95–22 and additional
documentation is estimated to be
$1,836.00.
Comments: Written comments are
solicited to (a) evaluate whether the
proposed data collection is necessary for
the proper performance of the agency,
including whether the information shall
have practical utility; (b) evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) enhance the quality, utility, and
clarity of the information to be
collected; and (d) minimize the burden
VerDate Aug<31>2005
19:28 Aug 07, 2007
Jkt 211001
of the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses. Comments must be
submitted on or before October 9, 2007.
Interested persons should
submit written comments to Chief,
Records Management and Privacy,
Information Resources Management
Branch, Information Technology
Services Division, Federal Emergency
Management Agency, 500 C. Street,
SW., Room 609, Washington, DC 20472.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Contact Chuck Burkell, (301) 447–1072
for additional information. You may
contact the Records Management
Branch for copies of the proposed
collection of information at facsimile
number (202) 646–3347 or e-mail
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
address: FEMA-InformationCollections@dhs.gov.
Dated: July 31, 2007.
John A. Sharetts-Sullivan,
Director, Office of Records Management,
Office of Management Directorate, Federal
Emergency Management Agency, Department
of Homeland Security.
[FR Doc. E7–15430 Filed 8–7–07; 8:45 am]
BILLING CODE 9110–17–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, DHS.
AGENCY:
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Notices]
[Pages 44561-44562]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15477]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0286]
Guidance for Industry: Class II Special Controls Guidance
Document: In Vitro Human Immunodeficiency Virus Drug Resistance
Genotype Assay; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry: Class II
Special Controls Guidance Document: In Vitro HIV Drug Resistance
Genotype Assay,'' dated August 2007. The guidance document provides a
means by which in vitro human immunodeficiency virus (HIV) drug
resistance genotype assays may comply with special controls for class
II devices. Elsewhere in this issue of the Federal Register, FDA is
publishing a final rule classifying the in vitro HIV drug resistance
genotype assay into class II (special controls). The guidance announced
in this notice finalizes the draft guidance entitled ``Guidance for
Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug
Resistance Genotype Assays: Special Controls'' dated August 2001.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448. Send one self-addressed adhesive label to assist the office
in processing your requests. The guidance may also be obtained by mail
by calling CBER at 1-800-835-4709 or 301-827-1800. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Class II Special Controls Guidance Document:
In Vitro HIV Drug Resistance Genotype Assay,'' dated August 2007. This
guidance document was developed as a special control to support
classification of the in vitro HIV drug resistance genotype assay from
class III to class II (special controls). Also, it is intended for use
in detecting HIV genomic mutations that confer resistance to specific
antiretroviral drugs as an aid in monitoring and treating HIV
infection.
In the Federal Register of August 29, 2001 (66 FR 45682), FDA
announced the availability of the draft guidance entitled ``Guidance
for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug
Resistance Genotype Assays: Special Controls'' dated August 2001. FDA
received several comments on the draft guidance and those comments were
considered as the guidance was finalized. The guidance announced in
this notice finalizes the draft guidance entitled ``Guidance for
Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug
Resistance Genotype Assays: Special Controls'' dated August 2001.
II. Significance of the Guidance
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E (regulations
governing premarket notification submissions) have been approved under
OMB control number 0910-0120.
IV. Comments
Interested persons may, at any time, submit written or electronic
comments to the Division of Dockets Management (see ADDRESSES)
regarding this guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in the brackets in the heading of this document. A copy of
the guidance and received comments are available for public examination
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/
ohrms/dockets/default.htm.
[[Page 44562]]
Dated: August 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15477 Filed 8-7-07; 8:45 am]
BILLING CODE 4160-01-S
